Validation, Verification and

Reassessment of the HACCP Plan

EIAO Training

Purpose of this Training

Promote understanding of validation,

ongoing verification, and reassessment.

Some establishments may not have adequate in-

plant validation documentation and we want to

demonstrate how to verify this.
HACCP system validation is vital to the
production of safe, unadulterated product.
Inspection personnel must evaluate an
establishments validation documentation to
verify the adequacy of its HACCP system.
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Session Objectives
Define validation, verification, and reassessment
Describe how validation documentation is a form of

supporting documentation

Explain the necessary elements of validation

Describe how to verify the validation requirement
Identify situations clearly representing a

noncompliance with 9 CFR 417.4(a)(1)

Terminology
The term Verification can be confusing

because it is used for different activities

depending upon the context.

Terminology
Verification (Usage 1)
One of the seven HACCP Principles
Broad meaning of the term
Activities other than monitoring that determine that the
HACCP system is functioning as intended
This encompasses:
Initial Validation
Ongoing Verification
Reassessment
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Terminology
Ongoing Verification (Usage 2)
More narrow term
Specific activities that occur on an ongoing basis to

ensure that the HACCP plan is being followed

Examples
Sampling
Calibration
Direct observation of monitoring
Records review
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Terminology
Verification by USDA (Usage 3)
Procedures FSIS employees use to determine if

regulatory requirements are met

Validation Requirements

What is Validation?
The act or process of ensuring the HACCP

system is valid

Valid: Well grounded or justifiable, relevant

and meaningful, logically correct

HACCP Validation Requirement

9 CFR 417.4 (a)(1)
...the establishment shall conduct activities

designed to determine that the HACCP plan is

functioning as intended. During this validation
period, the establishment shall repeatedly test the
adequacy of the CCPs, critical limits, monitoring,
and recordkeeping procedures, and corrective
actions set forth in the HACCP plan. Validation also
encompasses reviews of the records themselves,
routinely generated by the HACCP system, in the
context of other validation activities.

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Requirements - 9 CFR 417.4

Validation: Demonstrates that the HACCP system

can and does work as intended under plant

conditions.

On-going verification: Demonstrates that the

establishment continues to produce safe,

unadulterated products.

Reassessment: Response to situations that may

affect the effectiveness of the HACCP system or

the establishments ability to carry it out.

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Validation vs. Verification

Validation: process of demonstrating that

the HACCP system as designed can

adequately control identified hazards to
produce a safe, unadulterated product.

Verification: ongoing activities that

demonstrate conformance to the HACCP

system

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Validation of Prerequisite Programs

Prerequisite programs support hazard analysis

decisions by preventing hazards.

Effective HACCP system depends on

prerequisite programs preventing applicable

hazards under actual plant conditions

Effective HACCP system depends on the

establishment implementing prerequisite

programs as written.

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Two Parts of Validation

Theoretical support
scientific or technical support for judgments made in

designing the HACCP system

Initial In-plant validation

evidence derived from the HACCP plan in operation to

demonstrate that it is in fact achieving the parameters

and results that would be expected from the scientific
or technical support

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Scientific and Technical Support

Scientific or technical documentation to show that

the measures adopted in its HACCP systems

effectively control identified food safety hazards.

Agency guidance documents

documented expert advice from processing authorities
an article from a peer- reviewed journal or documented

scientific study
documented results from a pathogen modeling program
Corporate in-house challenge studies

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Scientific and Technical Support

Characteristics
Scientific Support Characteristics
Identify hazard and pathogen
Sufficient relationship to hazard
Level of reduction
Identify critical parameters
Implemented in the plant as documented
Additional research data that may be needed

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Initial In-Plant Validation

Data collected to repeatedly test the

adequacy of the components of the HACCP

system to demonstrate that:
The establishment can meet the parameters

specified in the scientific documentation under

in-plant conditions

The HACCP system, as implemented, achieves

the expected results

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Initial In-Plant Validation

Examples of data sources:
in-plant observations
measurements
microbiological test results
Often the same observations and

measurements become the ongoing

monitoring and verification procedures
once the HACCP system is validated

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Initial Inplant Validation

During initial 90-day validation period

described in 9 CFR 304.3 and 381.22 for new

establishments or new processes in existing

Validation also required when the HACCP

system is modified in a way that makes the

prior validation data obsolete

Documentation becomes records under 9 CFR

417.5(a)(1) supporting documentation

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Initial In-Plant
Validation Characteristics
Based on the critical parameters identified

in the scientific support

Intensified data collection during the first 90

days repeatedly testing - NOT recreating

the entire scientific support

May include microbial testing at control steps to

demonstrate log reductions are achieved

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What requires validation?

CCPs
Interventions during slaughter
RTE post-lethality controls
Pre-requisite programs designed to prevent a hazard

from being likely to occur

Product formulations
Cooking Instructions
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In-plant Validation Data Uses

Repeatedly testing data can potentially be used as

supporting documentation for frequencies

Establish a baseline of performance

Data can show which critical parameters are most

important and give the first signs the system is out

of control

Product formulations that influence product safety

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Non-compliance Examples
The establishment references a peer

reviewed journal article as supporting

documentation, but cant produce the
article upon request.
The establishment had a validated process
on file but did not follow the process as
described.

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Noncompliance Examples
A process that is validated for a specific log

reduction of a pathogen in a product other

than meat and poultry is being used as sole
supporting documentation

The plant references time/temperature

values from Appendix A, but fails to reach

the required values

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Noncompliance Examples
No records that demonstrate the initial

validation of the HACCP system

Critical parameter data

Micro data related to hazards identified in

hazard analysis

No records that demonstrate ongoing

effectiveness of the Prerequisite programs

and HACCP plan

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Validation Main Points

Validation includes the HACCP System
Initial Validation is within the first 90 days
There are two parts to Validation:
Scientific - technical support for HACCP system
Initial practical in-plant demonstration proving
HACCP system can perform as expected

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Validation Critical Parts

Remember these two critical parts of

assessing Validation:

Validation encompasses review of the records

generated by the HACCP plan, and

Every aspect of the food safety system must be

validated including prerequisite programs

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Ongoing Verification
Requirements

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Regulations
9CFR 417.2(c)(7)
9CFR 417.4(a)(2)(i)(ii)(iii)

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Gather Information
Does the HACCP plan contain:
Procedures and frequencies for calibration of

process-monitoring instruments?

Procedures and frequencies for direct

observation of monitoring activities and

corrective actions?

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Gather Information
Does the HACCP plan list:
Procedures and frequencies for the review of

records generated and maintained in

accordance with 9 CFR 417.5(a)(3)?

Product sampling as a verification activity?

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Gather Information
Are process-monitoring instrument calibration

activities conducted as per the HACCP plan?

Are direct observation verification activities

conducted as per the HACCP plan?

Are records generated in accordance with 9

CFR 417.5(a)(3) being reviewed by the

establishment?

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Assess Information
Review HACCP plan

Review HACCP records

Observe plant employees

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Reviewing HACCP Plan

Are procedures and frequencies for all 3

activities included?
Calibration
Direct observation
Records review

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Reviewing HACCP Plan

Calibrating monitoring equipment, direct

observations, and records reviews do not

have to all be addressed at each CCP, but all
3 should be addressed in the plan

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Reviewing HACCP Plan

Some HACCP plans might not contain all 3

activities

Example - CCP monitored without process

monitoring equipment

Example - Continuous monitoring equipment

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Reviewing Verification Records

Are verification procedures performed at

the frequency described in HACCP plan?

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Observing Plant Employees

Are verification procedures carried out as

written in the HACCP plan?

Direct observation means observing the plant

employee conducting monitoring

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Observe product sampling

If product sampling is included in

verification activities

Observe employee take sample

Review results

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Knowledge Check
What are the three types of on going

verification activities listed in the

regulations?

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Knowledge Check
What are the three types of verification

activities listed in the regulations?

Calibration
Direct Observation of Monitoring
Records Review

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Knowledge Check
What are three activities you may use to

verify the verification requirement?

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Knowledge Check
What are three activities you may use to
verify the verification requirement?

Review HACCP plan

Review HACCP records
Observe establishment employees

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Reassessment Requirement

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Reassessment of the HACCP Plan

Annual Requirement
Process Change
417.4(a)(3)(i)(ii)
Establishment Training
417.7

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Reassessment of the HACCP Plan

Annual requirement
Reassess annually
HACCP plan signed and dated
417.2(d)(iii)

Reassessment must be documented under

417.4(a)(3)(ii)
If changes made must document the reason
If no changes on annual reassessment no need to

document

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Training Requirement
417.7
HACCP trained person involved in development
and reassessments
No documentation required to verify
HACCP

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Reassessment Due to Process Changes

Reassessment is required for changes that

could alter the hazard analysis

If plan no longer meets regulatory
requirements modify immediately
Required to document reassessment under
417.4(a)(3)(ii) and document the reason for
changing or for not changing

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Possible Process Changes

raw materials or source

of raw materials

product formulation

distribution systems

slaughter or processing

intended use or

production volume

personnel

methods or systems

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packaging

consumers

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Gather Information
Did the establishment perform the annual

reassessment of its plan or plans at some

point during the previous calendar year?

Did the establishment consider any

significant developments that have

occurred in the plant in its analysis?

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Gather Information
Has a change occurred that could affect the

hazard analysis or HACCP plan?

Did the establishment reassess?

If the reassessment revealed that the

HACCP plan no longer met regulatory

requirements, was the HACCP plan modified
immediately?

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Gather Information
Did the establishment sign and date the

plan during the previous calendar year and

upon any modification to the plan?

Has the individual who reassessed the

HACCP plan or who modified the plan,

completed training in the 7 HACCP
principles including a segment on HACCP
plan development and review of records?

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Assess Information
To obtain answers, review
Reassessment records
HACCP plan

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QUESTIONS?

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Validation, Verification, Reassessment

Workshop I
In your groups look at the Jerky Hazard

Analysis and HACCP plan.

Report out findings and any concerns you
may have

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Validation, Verification, Reassessment

Workshop II
Discuss in your groups the regulatory

statutory basis for an NOIE for failure of an

establishment to perform calibration of
process monitoring instruments as stated in
the HACCP plan.
Report out

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